The health care reform legislation signed into law by President Obama March 23 paves the way for the launch of biosimilar drugs in the U.S., action that could save the country's health care system billions of dollars, while presenting both challenges and opportunities for the drug industry.
Article preview reprinted from "The Pink Sheet"- March 29, 2010
The health care reform legislation signed into law by President Obama March 23 paves the way for the launch of biosimilar drugs in the U.S., action that could save the country's health care system billions of dollars, while presenting both challenges and opportunities for the drug industry.
Availability of biosimilars - low cost versions of protein-based biologic drugs - will put additional pressure on biologic drug manufactures, which have not had to grapple with the same limited marketing exclusivity periods and patent cliffs for biologics that small molecule drugs have been subject to for two decades. Ultimately, the legislation establishes a legal framework for biosimilar drugs and is a win for the branded drug industry, offering a lengthy 12 years of marketing exclusivity for innovator products.
For some drug makers, biosimilars will be another roadblock on the long-term growth path - though how significant an impact biosimilars will ultimately have on brands remains to be seen. But for others they represent an opportunity, a chance to get an early foot in the door in a potentially high profit-margin business.
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